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NCT05878860 · ClinicalTrials.gov registry record · Phase 1
ATSN-201 Gene Therapy in RS1-Associated X-linked Retinoschisis
A Phase 1 study of X-linked Retinoschisis, sponsored by Atsena Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
- 4
- Study locations
NCT05878860: Recruiting Phase 1 study of X-linked Retinoschisis, sponsored by Atsena Therapeutics.
NCT05878860 is a Phase 1 study of X-linked Retinoschisis that is actively recruiting participants, run by Atsena Therapeutics. The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05878860, a Phase 1 study of X-linked Retinoschisis, is actively recruiting participants, sponsored by Atsena Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
- 4
- Study locations
Study Summary
This study will evaluate the safety and tolerability of ATSN-201 in male subjects ≥ 6 years of age with RS1-associated X-linked retinoschisis (XLRS).
Primary Outcome
Incidence of dose-limiting toxicities (DLTs) and treatment-emergent adverse events (TEAEs).
Conditions Studied
Interventions
- BIOLOGICAL ATSN-201
Study Locations (4)
California
- Children's Hospital of Los Angeles - Los Angeles
Florida
- Bascom Palmer Eye Institute - Miami
Oregon
- Oregon Health Sciences University - Portland
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2023-08-22 |
| Est. Completion | 2029-10 |
| Phase | Phase 1 |
What NCT05878860 shows while recruiting
NCT05878860 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).
The record links to 1 condition, with X-linked Retinoschisis appearing as the primary indexed condition, and to 1 intervention - of which ATSN-201 is the first listed.
NCT05878860 reports a single indexed study location in California, Florida, Oregon.
Frequently Asked Questions
What is clinical trial NCT05878860 about?
NCT05878860 is a clinical study titled "ATSN-201 Gene Therapy in RS1-Associated X-linked Retinoschisis". This study will evaluate the safety and tolerability of ATSN-201 in male subjects ≥ 6 years of age with RS1-associated X-linked retinoschisis (XLRS).
What is the current status of trial NCT05878860?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2023-08-22. Estimated completion is 2029-10.
What conditions does trial NCT05878860 study?
This clinical trial studies the following conditions: X-linked Retinoschisis.
What interventions are being tested in trial NCT05878860?
The interventions under investigation include: ATSN-201 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05878860?
This trial is sponsored by Atsena Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05878860 being conducted?
This trial has 4 study locations across California, Florida, Oregon, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for X-linked Retinoschisis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05878860's enrollment target sits among peer trials
21 1616th of 2000 higher than 372 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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